XIAMEN CHINA, May 12, 2026 — Amoy Diagnostics Co., Ltd. (“AmoyDx”), a leading company in oncology companion diagnostics, announced today that the AmoyDx® Pan Lung Cancer PCR Panel (“the AmoyDx PLC Panel”) has received approval from the National Medical Products Administration (NMPA) in China. The panel’s RET gene fusion detection is now officially approved as a companion diagnostic for Selpercatinib capsules (Retsevmo®).
Developed using cutting-edge PCR technology, the AmoyDx PLC Panel enables the simultaneous detection of activating alterations in 11 key driver genes: EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3. Among them, EGFR, ALK, ROS1, MET, KRAS and RET have received NMPA approval for companion diagnostic use, guiding the clinical application of nine different targeted therapies in China.
The AmoyDx PLC Panel has been approved for marketing in China, Japan, and Europe. Globally, seven genes within the panel are approved for companion diagnostics, supporting treatment decisions for up to 23 targeted drugs for NSCLC patients worldwide.
AmoyDx remains committed to advancing precision oncology through regulatory excellence and continuous innovation in companion diagnostics. By collaborating with domestic and international partners, the company aims to expand access to advanced treatment strategies and improve outcomes for cancer patients.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
Developed using cutting-edge PCR technology, the AmoyDx PLC Panel enables the simultaneous detection of activating alterations in 11 key driver genes: EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3. Among them, EGFR, ALK, ROS1, MET, KRAS and RET have received NMPA approval for companion diagnostic use, guiding the clinical application of nine different targeted therapies in China.
The AmoyDx PLC Panel has been approved for marketing in China, Japan, and Europe. Globally, seven genes within the panel are approved for companion diagnostics, supporting treatment decisions for up to 23 targeted drugs for NSCLC patients worldwide.
AmoyDx remains committed to advancing precision oncology through regulatory excellence and continuous innovation in companion diagnostics. By collaborating with domestic and international partners, the company aims to expand access to advanced treatment strategies and improve outcomes for cancer patients.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
AmoyDx® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic For RYBREVANT® or RYBROFAZ® plus Chemotherapy
Next
Subscribe
to our
newsletter